Over The Counter (OTC) Non-Prescription (Category 4) Drugs

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An OTC Non-Prescription Drug is classified by Health Canada's Food and Drugs Act as a drug but can contain both Non-Prescription Drug ingredients and Natural Health Product ingredients.

The Food and Drugs Act defines a Drug as, "any substance or mixture of substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

(b) restoring, correcting or modifying organic functions in human beings or animals, or

(c) disinfection in premises in which food is manufactured, prepared or kept"

OTC Non-Prescription Drugs must receive a Drug Identification Number (DIN) to be sold in Canada.

You must complete a DIN Submission for Health Canada and ensure labels are compliant with Health Canada's rules and regulations.

Typically, it takes 45 calendar days to receive a DIN following submission of application, but this can vary depending on ingredients present.